Recall Z-2652-2023— GE MEDICAL SYSTEMS, ISRAEL LTD.

Name: FDA recall Z-2652-2023
Creator: U.S. Food and Drug Administration
Published: 2023-09-06

Class II · Ongoing

Class II FDA medical device recall by GE MEDICAL SYSTEMS, ISRAEL LTD., initiated 2023-09-06. It names 3 FDA 510(k) clearances: K220800, K202233, K183362. Product: Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system. Reason: Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling..

Recalling firm: GE MEDICAL SYSTEMS, ISRAEL LTD.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-06
Firm location: HAIFA, N/A, Israel

510(k) clearances named in this recall

3 on FDA's record

K220800 — Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2022-06-21
K202233 — Venue GoGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2020-11-18
K183362 — Venue GOGE Medical Systems Ultrasound and Primary Care Diagnostics·cleared 2019-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system

Reason for recall

Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.